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Efficacy of early administration of thrombomodulin alfa in patients with sepsis-induced disseminated intravascular coagulation: subanalysis from post-marketing surveillance data

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Introduction

We hypothesize that the early administration of thrombomodulin alfa (TM-alfa) (Recomodulin® injection; Asahi Kasei Pharma Corporation, Tokyo, Japan) could improve mortality in patients with sepsis-induced disseminated intravascular coagulation (DIC). TM-alfa has been approved for use as a curative medicine for DIC in Japan from 2008 that was examined in a multicenter, randomized, clinical trial [1].

Methods

DIC was diagnosed based on the Japanese Association for Acute Medicine (JAAM) criteria. From May 2008 to April 2010, a total of 1,787 patients with sepsis-induced DIC from post-marketing surveillance data [2] were analyzed. The survival rates on day 28 after the last TM-alfa administration were evaluated.

Results

The 28-day survival rate was 64.5%. Use of other anticoagulants before and after TM-alfa administration did not affect the survival rate (present vs. absent: 63.8% vs. 65.2% (P = 0.782) and 62.5% vs. 65.3% (P = 0.606) respectively). The survival rate decreased significantly in proportion to the duration of DIC before TM-alfa administration (P < 0.001). More precisely, the 28-day survival rate was 66.4% when TM- alfa was injected on the same day that DIC was diagnosed, whereas it was 48.5% and 31.1% when TM-alfa was started 4 days later and 7 days or more after DIC was diagnosed, respectively. These differences were significant (P = 0.033 and P < 0.001, respectively).

Conclusion

The early administration of TM-alfa may be effective for patients with sepsis-induced DIC diagnosed based on the JAAM criteria.

References

  1. 1.

    Saito H, et al.: J Thromb Haemost. 2007, 5: 31-41. 10.1111/j.1538-7836.2006.02267.x

  2. 2.

    Mimuro J, et al.: Thromb Res. 2013, 131: 436-443. 10.1016/j.thromres.2013.03.008

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Author information

Correspondence to Y Eguchi.

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Eguchi, Y., Gando, S., Ishikura, H. et al. Efficacy of early administration of thrombomodulin alfa in patients with sepsis-induced disseminated intravascular coagulation: subanalysis from post-marketing surveillance data. Crit Care 18, P248 (2014). https://doi.org/10.1186/cc13438

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Keywords

  • Public Health
  • Clinical Trial
  • Survival Rate
  • Emergency Medicine
  • Disseminate Intravascular Coagulation